System and method for electro-cardiogram (ecg) medical data collection wherein physiological data collected and stored may be uploaded to a remote service center

ABSTRACT

A data collection unit obtains physiological data from a subject interface on a subject. The subject interface can be connected to the data collection unit. When the subject interface is connected to the data collection unit, subject interface contacts on the subject interface make contact with data collection unit contacts on the data collection unit. Some of the data collection unit contacts are for communicating physiological data from the subject interface to the data collection unit. Some of the contacts are for powering the data collection unit upon the subject interface being connected to the data collection unit and for powering down the data collection unit upon the subject interface being disconnected from the data collection unit.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to pending U.S. Provisional ApplicationSer. No. 61/409,521, entitled “Medical Data Collection Apparatus”, filedon Nov. 2, 2010, the entire contents of which are incorporated herein byreference.

BACKGROUND

Physiological activity of various organs, such as the heart or brain,can be monitored, and this physiological activity can be analyzed tolook for patterns that may assist in diagnosing various conditions. Forexample, the electrical activity of the heart can be monitored to trackvarious aspects of the functioning of the heart. Cardiac electricalactivity can be indicative of disease states or other physiologicalconditions ranging from benign to fatal. Cardiac monitoring devices cansense the cardiac electrical activity of a living being.

SUMMARY

This document describes systems and techniques by which physiologicaldata for an individual (e.g., a patient or test subject) can be obtainedcorresponding to a physiological characteristic such as cardiac activityand analysis of that physiological activity can be performed by a remotedata processing center. For example, a subject can be provided with aphysiological data collection device such as a monitoring device formonitoring a physiological signal for events (e.g. arrhythmia events,QRS data, etc.), a recording device, or the like. The physiological datacollection device can obtain, for example, ECG data from the subject fora predefined period of time and can store the ECG data on a storagemedium in the physiological data collection device. As described in moredetail below, the physiological data collection device can include adata connector such as a USB connector so the subject can directlyconnect the physiological data collection device to a computer systemsuch as the subject's personal computer. Also, the physiological datacollection device can be provided with program code that allows thesubject to automatically upload the obtained physiological data to aremote data processing center when the physiological data collectiondevice is connected to a computer using the USB connector.

The uploaded data can be analyzed by a computer running an analysisprogram at the remote data processing center. A medical professional,such as a doctor or a technician, can provide feedback regarding theanalysis. Based on the analysis and the feedback, a report can beprovided to the subject from the data processing center indicating theextent to which abnormal and/or clinically significant events weredetected during the predefined period of time. The report can alsoinclude a recommendation to consult further with a physician based onclinically significant events identified in the uploaded data.

The physiological data collection device can include a subject interfaceand a data collection unit. The subject interface can physicallyinterface with the subject for obtaining physiological data from thesubject. The subject interface can include, for example, a lead-wire sethaving multiple electrode leads that are removably connected to the datacollection unit. Data can be obtained using electrodes attached to theelectrode leads and stored on non-volatile memory in the data collectionunit. The data collection unit and/or the lead-wire set can beconfigured so that when the lead-wire set is connected to thephysiological data collection unit, a data connector on the datacollection unit is prevented from being connected to an external devicesuch as the subject's personal computer.

Also, data can be automatically obtained from the subject interface bythe physiological data collection device upon the subject interfacebeing physically connected to the physiological data collection unit.Also, the physiological data collection device can also include a powersupply that powers the physiological data collection device. The datacollection unit and the subject interface can be configured such thatthe power supply powers the physiological data collection device onlywhen the subject interface is connected to the physiological datacollection unit. In some examples, the power supply can be included inthe subject interface. When the power supply (e.g. a battery) dies, thesubject interface, including the power supply, can be disposed of and anew subject interface with a fresh battery can be connected to the datacollection unit so that the data collection unit can be re-used.

In a first aspect, a physiological data collection device can include anelectro-cardiogram (ECG) lead-wire set; a data collection unitincluding: a data connector for connecting to an external computingdevice, a lead-wire set connector for connecting to the ECG lead-wireset, and non-volatile memory coupled with the data connector and thelead-wire set connector, and a processor programmed to obtain ECG datafrom the ECG lead-wire set and store the obtained ECG data in thenon-volatile memory; and wherein the ECG lead-wire set or the datacollection unit or both have one or more structural components thatprevent a connection between the data connector and the computer whenthe ECG lead-wire set is connected to the data collection unit and viceversa.

Implementations can include any or all of the following features. Thedata connector can include a male USB connector. The lead-wire setincludes a female receptacle that is configured to receive the male USBconnector when the lead-wire set is connected to the data collectionunit. The lead-wire set includes an electrode connector having lead-wireset contacts; the lead-wire set interface includes an electrodeconnector receptacle having data collection unit contacts; and theelectrode connector receptacle is configured to receive the electrodeconnector such that the lead-wire set contacts make contact with thedata collection unit contacts when the lead-wire set is connected to thedata collection unit. The USB connector is configured to rotate into arecess in the data collection unit; and when the USB connector isrotated into the recess, the lead-wire set interface is exposed so thatthe lead-wire set can be connected to the data collection unit via thelead-wire set interface and the recess blocks a connection of the USBconnector to the computer. The male USB connector includes standard USBcontacts and customized data collection unit contacts; and the lead-wireset connects to the male USB connector such that the lead-wire setinterface interfaces with the lead-wire set via the customized datacollection unit contacts in the USB connector.

In another aspect, an electro-cardiogram (ECG) self-assessment kitincludes: an ECG subject interface including one or more electrodeleads; multiple ECG electrodes configured to connect to the one or moreelectrode leads; a power source; a portable subject ECG data collectionunit including: a USB connector configured to interface with a USB porton a computer, non-volatile memory coupled with the USB connector, and aprocessor powered by the power source and programmed to obtain ECG datafrom the electrode leads and to store the ECG data in the non-volatilememory; and a medium storing program code that when run by the computersupports access to a remote data processing center for uploading the ECGdata from the non-volatile memory to the remote data processing centerwhen the USB connector is connected to a computer connected to anetwork.

Implementations can include any or all of the following features. Thedata collection unit includes the medium storing program code. Theprogram code when run by the computer supports access to the remote dataprocessing center for uploading the ECG data without installing asoftware application on the computer. The program code when run by thecomputer supports access to the remote data processing center byautomatically initiating an application for uploading of the ECG dataupon determining that the USB connector is connected to the computer.The program code including a link to a website where the ECG data can beuploaded. The program code supports access to the data processing centerby supporting a download from a remote server system to the computer ofa user application for uploading the ECG data to the remote dataprocessing center. The subject interface is configured to be physicallyattached to the ECG data collection unit; and when the subject interfaceis connected to the ECG data collection unit, the USB connector isblocked so that the USB connector cannot be connected to the computer.The USB connector includes male USB connector that is received into areceptacle in the subject interface when the subject interface isconnected to the data collection unit.

The non-volatile memory has sufficient memory to store ECG data for apredefined time period; and wherein the power source has sufficientpower to power the data collection unit for the predefined time period.The program code, when run by the computer, obtains and presents an ECGassessment report from the data processing center. The subject interfaceincludes: a clip for securing the subject interface to the datacollection unit; and a lanyard that allows the data collection unit tobe hung from the neck of a subject when the subject interface is securedto the data collection unit. The subject interface includes the powersource.

In another aspect, a method of providing a data analysis serviceincludes: providing a physiological data collection device to a subject,the physiological data collection device including: anelectro-cardiogram (ECG) subject interface; a data collection unitincluding a USB data connector for connecting to a computer, aninterface for connecting to the subject interface, non-volatile memorycoupled with the data connector, and a processor programmed to obtainECG data from the subject interface and store the ECG data in thenon-volatile memory; obtaining, at a remote data processing center, theECG data from the data collection unit when the data collection unit isconnected to a USB data port on a computer having a network connection;analyzing the ECG data for arrhythmia events; obtaining a physicianreview of the ECG data; and providing a report over the network to thesubject based on the analyzing the ECG data and based on the physicianreview.

Implementations can include any or all of the following features. Theobtaining the ECG data includes obtaining the ECG data via atransmission of the ECG data over the network wherein the transmissioninitiates automatically upon a determining that the data collection unitis connected to the USB data port. The USB data connector includes amale USB data connector. Obtaining, at the remote data processingcenter, a unique identifier from the data collection unit; verifyingbased on the unique identifier that the physiological data collectiondevice has been preauthorized for the steps of analyzing, obtaining aphysician review, and providing; and performing the steps of analyzing,obtaining a physician review, and providing only upon successfulverification. The verifying further includes determining that a dataanalysis service has not already been performed for the physiologicaldata collection device.

The method further includes providing a medium storing program code thatwhen run by the computer supports access to the remote data processingcenter for uploading the ECG data from the non-volatile memory to theremote data processing center when the USB data connector is connectedto a computer connected to a network. The non-volatile memory includesthe medium.

In another aspect, a subject electro-cardiogram (ECG) data collectiondevice includes: a removable ECG subject interface having subjectinterface contacts; a power source; a data collection unit including: aprocessor programmed to obtain physiological data from the ECG subjectinterface and store the physiological data in non-volatile memory, adata connector configured to be physically connected to a universal dataport on a computer, and data collection unit contacts configured to bephysically connected to the subject interface contacts on the ECGsubject interface; the physiological data collection device configuredto provide power from the power source to the processor upon the ECGsubject interface being connected to the data collection unit and tointerrupt power from the power source upon disconnection of the ECGsubject interface from the data collection unit.

Implementations can include any or all of the following features. Thesubject interface includes a lead-wire set. The ECG subject interfaceincludes the power source. The data collection unit includes thenon-volatile memory. The data connector includes a male USB connector.The physiological data collection device is further configured to detectpower provided by the computer when the data connector is connected tothe computer and to upload the physiological data stored in thenon-volatile memory to a remote service center via the computer when thedata connector is connected to the computer. The data collection unit isconfigured to stop providing power from the power source when the ECGsubject interface is disconnected from the data collection unit. Thesubject interface contacts comprise a first subject interface contactand a second subject interface contact that: when not connected to acorresponding first data collection unit contact and a second datacollection unit contact, are configured to create an open circuit, andwhen connected to the corresponding first data collection unit contactand a second data collection unit contact, are configured to create aclosed circuit. The data collection unit is further configured toautomatically obtain data from the ECG subject interface upon the ECGsubject interface being connected to the data collection unit. The datacollection unit is further configured to automatically stop obtainingdata from the ECG subject interface upon the ECG subject interface beingdisconnected from the data collection unit. The first data collectionunit contact is in series with the second data collection unit contact;and wherein the ECG subject interface, when connected to the datacollection unit, is configured to bring the first data collection unitcontact into electrical connection with the second data collection unitcontact. The subject interface contacts include a third subjectinterface contact and a fourth subject interface contact for bringingelectrodes on the ECG subject interface into electrical communicationwith the processor. The subject interface connector includes a fifthsubject interface contact that is configured to interrupt the processorwhen the ECG subject interface is disconnected from data collectionunit.

In another aspect, a method includes: powering an electro-cardiogram(ECG) data collection unit upon an ECG subject interface beingphysically connected to the ECG data collection unit, the connected ECGsubject interface creating a closed circuit with a power source forpowering the ECG data collection unit; obtaining, using a processor,data from the ECG subject interface and storing the data on non-volatilememory; and powering-off the ECG data collection unit upon the ECGsubject interface being physically disconnected from the ECG datacollection unit and thereby creating an open circuit with the powersource.

Implementations can include any or all of the following features. TheECG subject interface includes a lead-wire set. The obtaining and thestoring include obtaining and storing the data on non-volatile memoryautomatically upon the ECG subject interface being physically connectedto the ECG data collection unit. The method further includesautomatically initiating an upload, over a network, of the data storedon the non-volatile memory to a remote service center via a computerupon a data connector on the data collection unit being physicallyconnected to the computer. The data connector includes a male USBconnector; and wherein connecting the data connector on the ECG datacollection unit with the computer includes connecting the USB connectorwith the computer. The ECG data collection unit includes a first datacollection unit contact and a second data collection unit contact;wherein being physically connected includes bringing the first datacollection unit contact into electrical communication with the seconddata collection unit contact via the ECG subject interface and therebyclosing the circuit with the power source. The data collection unitincludes a third data collection unit contact and a fourth datacollection unit contact; and wherein being physically connected includesbringing a first and second electrodes on the ECG subject interface intoelectrical communication with the processor via the third datacollection unit contact and the fourth data collection unit contact. Thedata collection unit includes a fifth data collection unit contact thatcontacts a fifth subject interface contact on the ECG subject interfacewhen the ECG subject interface is connected to the data collection unit;and the method further includes sending an interrupt signal to theprocessor when the ECG subject interface is disconnected from the ECGdata collection unit. The ECG subject interface includes the powersource.

Details of one or more implementations are set forth in the accompanyingdrawings and the description below. Other features, aspects, andpotential advantages will be apparent from the description and drawings,and from the claims.

DESCRIPTION OF DRAWINGS

FIGS. 1-4 show various aspects of an example self-assessment kit forobtaining ECG data from a subject.

FIG. 5 shows an example system for uploading physiological data storedon a data collection unit.

FIG. 6 shows an example process for obtaining physiological data from asubject.

FIG. 7 shows a schematic of an example physiological data collectiondevice.

FIGS. 8A and 8B show an example data collection unit.

FIGS. 9A and 9B show an example data collection unit.

FIG. 10 shows a schematic of an example physiological data collectiondevice.

FIG. 11 shows a schematic of an example physiological data collectiondevice.

FIG. 12 shows a schematic of an example physiological data collectiondevice.

FIG. 13 shows an example process for powering an ECG data collectionunit.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

FIG. 1 shows an example of a self-assessment kit 100 for obtaining ECGdata from a subject. The self-assessment kit 100 includes a datacollection unit 105, a lead-wire set 110, electrodes 115 in the form ofremovable electrode patches, and program code 120 stored on a mediumsuch as a CD-ROM. The self-assessment kit allows a subject to obtain hisor her own ECG signal, upload ECG data to a remote data processingcenter, and obtain an assessment from the data processing center withoutthe need to involve a third-party medical practitioner such as aprescribing physician. Also, the self-assessment kit can be configuredto allow a subject to self-monitor his or her own ECG signal for aspecified period of time such as 14 days.

The lead-wire set 110 has a connector head 125, a first electrode lead121, and a second electrode lead 122. The connector head 125 isconfigured to be connected to the data collection unit 105. Whenconnected, the data collection unit 105 can be hung from the neck of thesubject using a lanyard 124 on the lead-wire set 110. The connector head125 also includes an electrode connector 170. The electrode connector170 is a male end with multiple lead-wire set contacts 171 at a distalend of the electrode connector 170.

The electrodes 115 are disposable electrode patches that can beconnected to distal ends of the first electrode lead 121 and the secondelectrode lead 122. The electrodes 115 have adhesive backing so thatthey can be stuck to the chest of the subject. The self-assessment kit110 can include enough disposable electrodes 115 for the specifiedperiod of time.

In use, the data collection unit 105 is connected to the connector head125, and one of the electrode patches is connected to the firstelectrode lead 121 and another of the electrode patches is connected tothe second electrode lead 122. A subject sticks the connected electrodesto his or her chest and wears the data collection unit 105 around his orher neck with the lanyard 124. The data collection unit 105 obtains anelectrical signal from the electrode patches connected to the firstelectrode lead 121 and the second electrode lead 122. The electricalsignal is converted to a digital signal and stored in the datacollection unit 105 as ECG data.

FIG. 2 shows a side perspective view of the data collection unit 105 andthe lead-wire set 110. When the connector head 125 is connected to thedata collection unit 105, a clip 250 on a side of the connector head 125clips into a clip receptacle 255 on the data collection unit 105 tosecurely fasten the lead-wire set 110 to the data collection unit 105.The other side of the connector head 125 has a similar such clip. Toremove the connector head 125 from the data collection unit 205, a usercan depress a thumb tab 256 on the clip 250 to disengage the clip 250from the clip receptacle 255.

FIG. 3 shows a front perspective view of a portion of the lead-wire set110, including the connector head 125. The connector head 125 has a USBconnector receptacle 390 adjacent to the electrode connector 170. FIG. 4shows a front perspective view of the data collection unit 105. The datacollection unit 105 includes a male USB connector 280 and a femaleelectrode connector receptacle 281 adjacent to the USB connector 280.The data collection unit 105 has data collection unit contacts 489inside the electrode connector receptacle 281. The USB connector 280also has standard USB contacts 499 inside the USB connector 280.

When the lead-wire set 110 is connected to the data collection unit 105,the electrode connector 170 on the connector head 175 is received intoelectrode connector receptacle 281 on the data collection unit 105, andthe lead-wire set contacts 171 make contact with the data collectionunit contacts 489. Also, when the connector head 125 is connected to thedata collection unit 105, the USB connector 280 is received into the USBconnector receptacle 390 on the connector head 125. In this manner, whenthe lead-wire set 110 is connected to the data collection unit 105, theUSB connector 280 cannot simultaneously be connected to an externaldevice such as a personal computer. This helps to protect a subject fromsimultaneously being connected with a power source for the datacollection unit 105 and with another power source in an external device.Accordingly, there is no need to provide the data collection unit 105with galvanic isolation circuitry to isolate the subject from the powersource of an external device connected to the data collection unit 105while the subject is connected to the data collection unit 105.

Also, when the lead-wire set 110 is connected to the data collectionunit 105, data can automatically be obtained from the lead-wire set 110and stored on the data collection unit 105. When the lead-wire set 110is disconnected from the data collection unit 105, the data obtainingand storing can be terminated automatically.

FIG. 5 shows an example system 500 for uploading the ECG data stored onthe data collection unit 105. The program code 120 can be run on acomputer system 510 such as the subject's personal computer. Thecomputer system 510 includes a computer and a display device. When thesubject has completed the data collection period, the subject candisconnect the data collection unit 105 from the lead-wire set 110 andconnect the USB connector 280 to the computer system 510. The programcode when run by the computer system 510, supports access to a remotedata processing center 520 so that the ECG data can be uploaded from thedata collection unit 105 over a network 515 to the remote dataprocessing center 520 where the physiological data is analyzed. Theprogram code can support access to the remote data processing center 520by automatically initiating a transmission of the ECG data stored on thedata collection unit 105 upon detecting that the data collection unit105 is connected to the computer system 510.

In some examples, the data processing center can obtain demographic dataabout the subject. Demographic data can assist in the analysis of thephysiological data obtained from the data collection unit. For example,a particular event detected in a physiological signal can be serious forone person and not serious for another based on demographics such asage. The program code, when run by the computer system 510, can alsofacilitate the data processing center obtaining demographic data aboutthe subject.

The data processing center 520 includes a computer 530 that analyzes thephysiological data for abnormal and/or clinically significant events.The computer 530 can determine, using predefined algorithms, arrhythmiasin the subject's ECG data and can provide a report to a medicalprofessional 540, such as a medical technician and/or a doctor. Themedical professional can review the reported arrhythmias in thesubject's ECG signal from a display device 533 connected the computer530 and provide feedback via input device 534 to the computer 530 as towhich events were accurately identified and which events wereinaccurately identified.

A report of the reviewed arrhythmic events can be compiled at the dataprocessing center 520 and provided to the subject. The report can beprovided to the subject over the network 515. The program code 120 caninclude code for a user application that presents the report to thesubject from the subject's computer system 510.

The program code 120 can be stored on a medium such as CD ROM as shownin FIG. 1. In some examples, the program code can be stored on a mediumon the data collection unit 105 such as non-volatile memory. In such anexample, when the subject plugs the data collection unit 105 into thesubject's computer system 510, the program code can be run by thesubject's computer system 510 to support access to the remote dataprocessing center 520 by automating the process of uploading the ECGfrom the data collection unit 105 to the data processing center 520, orby directing the subject to download, from a remote server system, anapplication for uploading the subject's ECG data. The program codestored on the data collection unit 105 can also include program codethat runs when the subject plugs the data collection unit 105 into thesubject's computer system 510 and directs the subject to an externallocation such as a website for uploading the ECG data on the datacollection unit 105 without installing an application on the subject'scomputer system 510.

A subject can use the self-assessment kit 100 to self-monitor byplugging the lead-wire set 110 into the data collection unit 105 whichin turn powers the data collection unit 105 and lead-wire set 110 andinitiates recording of data from the lead-wire set 110 to memory on thedata collection unit 105. When the subject is ready to upload the datato the remote data processing center, the subject can unplug thelead-wire set from the data collection unit 105 which powers down thedata collection unit 110 and lead-wire set and stops recording of data.The subject can then plug the data collection unit 105 into the computer510 connected to the network 515. The data can be automatically uploadedto the remote data processing center 520.

In some examples, the computer 510 can include a public terminal such asa kiosk specifically provided for obtaining the subject data from thedata collection unit and uploading the subject data to the dataprocessing center 520. The public terminal is provided in a publiclocation such as in a health care facility like a doctor's office, apharmacy, or the like. The public terminal can be pre-loaded with aprogram for obtaining the data from the data processing device anduploading the data over the network 515 to the data processing center520. The public terminal can also be configured to obtain thedemographic information from the subject when the subject uploads thedata. A report from the data processing center 520 can be viewed orprinted directly from the public terminal.

In some examples, the subject can provide the data collection unit 110to a third-party for uploading the data to the data processing center520. For example, the self-assessment kit can include a pre-paid packagefor mailing the data collection unit 110 to a third-party or directly tothe data processing center. The kit 100 can also include a questionnairefor the subject to fill-out to provide demographic data to facilitatedanalysis by the data processing center 520 and to provide a location fora report to be sent to the subject either by mail or electronically.

FIG. 6 shows an example process 600 for obtaining physiological datafrom a subject. At 610, a physiological data collection device isprovided to a subject. For example, the subject can purchase thephysiological data collection device as part of a self-assessment kitsuch as a one-time use self-assessment kit that is preauthorized toallow a subject to self-record his or her ECG signal for a predeterminedtime period and to receive an analysis service from a data processingcenter. The analysis service can include, for example, analysis of theECG signal for that predetermined time period. The kit can include allthe materials necessary for a subject to self-record his or her cardiacactivity for the predetermined time period and to obtain a report from adata processing center—including, for example, a data collection unit,electrode leads, sufficient disposable electrodes for the predeterminedtime period, and program code for allowing the subject to upload data tothe data processing center. The physiological data collection device canalso include unused memory just sufficient to store ECG data for thepredetermined time period, and a battery with just sufficient power foroperating the physiological data collection device for the predeterminedtime period. The physiological data collection device is also configuredto connect to a computer, such as a subject's personal computer.

At 620, the physiological data collection device is powered. Forexample, the physiological data collection device can be powered by aninternal battery when the subject connects the electrode leads to thedata collection unit, as discussed in more detail below in connectionwith FIGS. 10 and 13. Also, the data acquisition from the electrodeleads can be automatic upon the electrode leads being connected to thephysiological data collection device. At 630, ECG data from the subjectis stored in memory in the physiological data collection device. At 640,the subject connects the physiological data collection device to acomputer. The subject can connect the physiological data collectiondevice to the computer when the data collection is complete, such aswhen the memory is full, or when the battery dies. The subject connectsthe physiological data collection device to the computer using, forexample, a USB connector on the physiological data collection device.

The ECG data can be uploaded to the data processing center automaticallywhen the physiological data collection device is connected to thecomputer. For example, the computer can run a software application thatobtains data from the memory, including ECG data, and transfers the ECGdata to the data processing center. In some examples, such a softwareapplication can be installed on the computer. In some examples, programcode can be stored on the memory of the physiological data collectiondevice that auto-runs when the physiological data collection device isconnected to the computer. The auto-run program code can prompt the userto download an application from a remote server for uploading the datafrom the physiological data collection device. In some examples, theauto-run program code can direct the subject to a remote application,such as a website, that directs the subject to upload data from thephysiological data collection device without installing an applicationon the computer.

At 660, data from the physiological data collection device is obtainedby the data processing center. At 665, the data processing centerverifies, based on the uploaded data, whether the physiological datacollection device is pre-authorized for an analysis service. Forexample, the data processing center can check a unique identifier of thephysiological data collection device, such as a serial number, todetermine if the physiological data collection device is preauthorizedfor the analysis service. The data processing center can also check todetermine whether an analysis service has already been provided for thephysiological data collection device. If the physiological datacollection device is not pre-authorized, or if an analysis service hasalready been provided for the pre-authorized physiological datacollection device, the data processing center can indicate as much tothe subject and prompt the subject for payment for the analysis service.If authorization is verified and if a data processing service has notbeen provided for the physiological data collection device, the dataprocessing center, at 670, analyzes the ECG data from the physiologicaldata collection device for arrhythmia events. Predetermined computeralgorithms can be used to analyze the ECG data for arrhythmia events.

At 675, the data processing center can obtain feedback from a medicalprofessional, such as a medical technician and/or a doctor. For example,the identified arrhythmic events are provided to a medical professionalfor further analysis and/or review. The medical professional candetermine the accuracy of the identified events and provide feedback tothe data processing center. Based on the analysis performed at 670 andbased on the feedback 675, a report is provided to the subject at 680.At 690, the report is presented to the subject. The report can beprovided to the subject in various ways, such as by mail, by phone, byfax, by email, or by a software application. An application on thesubject's computer (such as an application used to upload ECG data tothe data processing center), can be configured to obtain the report fromthe data processing center and to present the report to the subject. Insome examples, the application can be a web-based application. Thesubject can be notified that his or her report is available. And, thesubject can log-on to the web-based application, to view the report. Thereport can also contain a recommendation to the subject to consult hisor her personal physician based on the results of the report, such aswhen the analysis identifies clinically significant arrhythmic events.

FIG. 7 shows a schematic of an example physiological data collectiondevice 700. The physiological data collection device 700 has a datacollection unit 705 and a lead-wire set 710. The data collection unit705 includes a battery 716 that powers processor electronics in the datacollection unit 705 including a processor 717 such as a multifunctionprocessor, memory 719, and an analog-to-digital (“A/D”) converter 725.The battery 716 can be large enough to run the physiological datacollection device 700 for a predefined time period. The memory can benon-volatile memory, such as flash memory. The lead-wire set 710includes electrodes 711 and 712 which are connected to electrode leads721 and 722. The electrode leads 721 and 722 are connected to alead-wire set connector 727 which in turn can be physically connected tothe data collection unit 705 via a lead-wire set interface 730.

Analog signal data is obtained from the lead-wire set 710 over thelead-wire set interface 730. The analog signal is digitized by the A/Dconverter 725 and stored by the processor in the memory 719. In order toreduce costs and size, the data collection unit 705 can have justsufficient memory 719 for storing the digitized data from a subjectobtained over a predefined time period. In some examples, the datacollection unit can have just sufficient memory for the digitized dataand for program code necessary for supporting access to a remote dataprocessing center so that the digitized data can be uploaded to the dataprocessing center.

The data collection unit 705 can be plugged into a computer via a dataconnector 745. The data connector 745 can be a USB data connector, afirewire connector, a serial port connector, or the like. When the datacollection unit 705 is plugged into a computer such as via USB, computerpower is sensed by the processor 717. The processor 717 can thentransfer the digitized data from the memory 719 to the computer foruploading to a remote data processing center.

FIGS. 8a and 8b show an example data collection unit 805. The datacollection unit 805 prevents a subject from connecting an electrode tothe data collection unit 805 at the same time the data collection unit805 is connected to an external device such as the subject's computer.As shown in FIG. 8a , the data collection unit 805 has a USB connector880 for connecting to an external computer. Data stored on the datacollection unit 805, such as ECG data, can be uploaded to a computer viathe USB connector 880.

When the data collection unit 805 is used to obtain ECG data, the USBconnector 880 is rotated 180 degrees so that the USB connector 880 isnestled in a recess 855 in the data collection unit 805 as shown in FIG.8b . When the USB connector 880 is nestled in the recess 855, a femaleelectrode connector receptacle 881 is exposed. The electrode connectorreceptacle 881 receives an electrode connector on a lead-wire set (notshown). The electrode connector has lead-wire set contacts that makecontact with data collection unit contacts 889 in the electrodeconnector receptacle 881 when the lead-wire set is connected to the datacollection unit 805. The lead-wire set contacts make contact with thedata collection unit contacts so that ECG data can be obtained from thelead-wire set. When the lead-wire set is connected to the datacollection unit 805, the USB connector 880 cannot be connected to acomputer or any other external device because the USB connector 880 isnestled in the recess 855.

In some implementations, a USB connector on a data collection unit canbe customized to include data collection unit contacts (in addition tothe USB contacts) so that a lead-wire set communicates with the datacollection unit through the USB connector by making contact with thedata collection unit contacts in the USB connector. The USB connectorcan still be used to connect the data collection unit to a computerbecause it has standard USB contacts.

FIGS. 9A and 9B show an example data collection unit 905. The datacollection unit 905 has a female electrode connector receptacle 981.Data collection unit contacts 989 are located inside the electrodeconnector receptacle 981. When a lead-wire set (not shown) is connectedto the data collection unit 905, an electrode connector on the lead-wireset is received into the electrode connector receptacle 981 on the datacollection unit 905, and lead-wire set contacts on the electrodeconnector make contact with the data collection unit contacts 989 sothat ECG data can be obtained by the data collection unit 905. The ECGdata can be digitized and stored on a removable USB device 948 in thedata collection unit 905. During data collection from the subject, theUSB device 948 is connected to the data collection unit 905 as shown inFIG. 9A. When the ECG data stored on the USB device needs to be uploadedto a computer, the USB device is removed from the data collection unit905 as shown in FIG. 9B. This configuration physically prevents asubject hooked-up to the data collection unit 905 from beingelectrically connect to an external device via USB device 948 becausethe USB device 948 must be removed from the data collection unit 905 inorder to be connected to a computer.

FIG. 10 shows a schematic of an example physiological data collectiondevice 1000. The physiological data collection device 1000 includes adata collection unit 1005 and a lead-wire set 1010. The data collectionunit 1005 includes a power source 1015 that provides power to anapparatus load 1047. The apparatus load can include, for example,processor electronics for obtaining and storing ECG data from thelead-wire set 1010, such as a processor, an A/D converter, non-volatilememory, etc. The data collection unit 1005 also includes a lead-wire setinterface 1030. The lead-wire set interface 1030 has five datacollection unit contacts—a first data collection unit contact 1089 a, asecond data collection unit contact 1089 b, a third data collection unitcontact 1089 c, a fourth data collection unit contact 1089 d, and afifth data collection unit contact 1089 e.

The lead-wire set 1010 has a lead-wire set connector 1027, a first andsecond electrode leads 1021 and 1022, and electrodes 1011 and 1012. Thelead-wire set connector 1027, when connected to the data collection unit1005, has five lead-wire set contacts—a first lead-wire set contact 1071a, a second lead-wire set contact 1071 b, a third lead-wire set contact1071 c, a fourth lead-wire set contact 1071 d, and a fifth lead-wire setcontact 1071 e—that make contact with the first data collection unitcontact 1089 a, the second data collection unit contact 1089 b, thethird data collection unit contact 1089 c, the fourth data collectionunit contact 1089 d, and the fifth data collection unit contact 1089 e,respectively.

Two of the lead-wire set contacts are for the electrode leads 1021 and1022, two are for powering the data collection unit 1005, and oneoptional the lead wire set contact is for interrupting the processorwhen the lead-wire set 1010 has been disconnected from the datacollection unit 1005. For example, the fourth lead-wire set contact 1071d and the fifth lead-wire set contact 1071 e are connected to the firstelectrode lead 1021 and the second electrode lead 1022. When the fourthlead-wire set contact 1071 d and the fifth lead-wire set contact 1071 eare in contact with the fourth data collection unit contact 1089 d andthe fifth data collection unit contact 1089 e, an ECG signal can beobtained by the data collection unit 1005 from the electrodes 1011 and1012.

When the lead-wire set 1010 and the data collection unit 1005 areconnected, the second lead-wire set contact 1071 b makes contact withthe second data collection unit contact 1089 b and the third lead-wireset contact 1071 c makes contact with the third data collection unitcontact 1089 c. The second and third lead-wire set contacts 1071 b and1071 c close an open circuit in the data collection unit 1005 when thelead-wire set connector is connected to the data collection unit 1005,allowing power to be supplied from the power source 1015 so that thesubject's ECG data can be obtained. This allows the data collection unit1005 to operate as soon as the lead-wire set 1010 is connected. When thelead-wire set 1010 is disconnected, an open circuit is created,terminating power supplied to the apparatus load from the power source1015. This helps prevent power leakage when the lead-wire set 1010 isdisconnected from the data collection unit 1005.

When the lead-wire set 1010 and the data collection unit 1005 areconnected, the first lead-wire set contact 1071 a makes contact with thefirst data collection unit contact 1089 a. When the lead-wire set 1010and the data collection unit 1005 are disconnected, contact is brokenbetween the first lead-wire set contact 1071 a and the first datacollection unit contact 1089 a, which in turn sends an interrupt signalto the processor in the data collection unit 1005. The interrupt signalstops the processor from recording data to the non-volatile memorybefore the capacitance in the opened circuit is lost. The interruptsignal helps prevent the non-volatile memory from becoming corrupted.

In some implementations, other circuitry, such as a real-time clock, canbe separately connected to the power source 1015 such that power issupplied to the other circuitry even upon the lead-wire set 1010 beingdisconnected from the data collection unit 1005. This allows an accuratedetermination of elapsed time for ECG data obtained by the lead-wire set1010. The elapsed time from the beginning of recording can be storedwith the ECG data obtained from the lead-wire set 1010. In someexamples, components not included in the apparatus load can be connectedto the power source 1015 separately, but in response to the lead-wireset 1010 being disconnected from the data collection unit 1005, thosecomponents can be placed into a standby mode—powered down to a loweroperational state to conserve power.

FIG. 11 shows a schematic of an example physiological data collectiondevice 1100. The physiological data collection device 1100 has a datacollection unit 1105 and a lead-wire set 1110. The lead-wire setincludes a lead-wire set connector 1127 for connecting the lead-wire set1110 to the data collection unit 1105. The lead-wire set 1110 includeselectrodes 1111 and 1112 which are connected to electrode leads 1121 and1122. The electrode leads 1121 and 1122 are connected to a lead-wire setconnector 1127 which in turn can be physically connected to the datacollection unit 1105 via a lead-wire set interface 1130. The lead-wireset also includes a battery 1116 in the lead-wire set connector 1127that powers the physiological data collection device 1100, includingprocessor electronics in the data collection unit 1105 such as aprocessor 1117, memory 1119 (e.g. non-volatile memory), and ananalog-to-digital (“A/D”) converter 1125. The battery 1116 can be largeenough to run the physiological data collection device 1100 for apredefined time period. For example, the battery can be large enough torun the physiological data collection device 1100 for a long enoughperiod of time to fill the memory 1119 with data obtained from thelead-wire set 1110. When the battery dies after the predefined timeperiod, it can be disposed of with the disposal of the lead-wire set1110. As a result, the data collection unit 1105 can be reused foranother predefined time period, upon the connection of another lead-wireset with a fresh battery. In some examples, upon the batter dying, thelead-wire set 1110 can be interchanged with another interchangeablelead-wire set with a new battery so that data collection can continue.In some examples, the battery can be removable; when the removablebattery dies, the removable battery can be replaced.

Analog signal data is obtained from the lead-wire set 1110 over thelead-wire set interface 1130. The analog signal is digitized by the A/Dconverter 1125 and stored by the processor 1117 in the memory 1119. Inorder to reduce costs and size, the data collection unit 1105 can havejust sufficient memory 1119 for storing the digitized data from asubject obtained over a predefined time period. In some examples, thedata collection unit 1105 can have just sufficient memory for thedigitized data and for program code necessary for supporting access to aremote data processing center so that the digitized data can be uploadedto the data processing center.

The data collection unit 1105 can be plugged into a computer via a dataconnector 1145. The data connector 1145 can be a USB data connector, afirewire connector, a serial port connector, or the like. When the datacollection unit 1105 is plugged into a computer such as via USB,computer power is sensed by the processor 1117. The processor 1117 canthen transfer the digitized data from the memory 1119 to the computerfor uploading to a remote data processing center.

FIG. 12 shows a schematic of an example physiological data collectiondevice 1200. The physiological data collection device 1200 includes adata collection unit 1205 and lead-wire set 1210. The lead-wire set 1210includes a power source 1215 that provides power to an apparatus load1247 when the lead-wire set 1210 is connected to the data collectionunit 1205. The apparatus load can include, for example, processorelectronics for obtaining and storing ECG data from the lead-wire set1210, such as a processor, an A/D converter, non-volatile memory, etc.The data collection unit 1205 also includes a lead-wire set interface1230. The lead-wire set interface 1230 has five data collection unitcontacts—a first data collection unit contact 1289 a, a second datacollection unit contact 1289 b, a third data collection unit contact1289 c, a fourth data collection unit contact 1289 d, and a fifth datacollection unit contact 1289 e.

The lead-wire set 1210 has a lead-wire set connector 1227, a first andsecond electrode leads 1221 and 1222, and electrodes 1211 and 1212. Thelead-wire set connector 1227, when connected to the data collection unit1205, has five lead-wire set contacts—a first lead-wire set contact 1271a, a second lead-wire set contact 1271 b, a third lead-wire set contact1271 c, a fourth lead-wire set contact 1271 d, and a fifth lead-wire setcontact 1271 e—that make contact with the first data collection unitcontact 1289 a, the second data collection unit contact 1289 b, thethird data collection unit contact 1289 c, the fourth data collectionunit contact 1289 d, and the fifth data collection unit contact 1289 e,respectively.

Two of the lead-wire set contacts are for the electrode leads 1221 and1221, two are for powering the data collection unit 1205, and oneoptional lead-wire set contacts is for interrupting the processor whenthe lead-wire set 1210 has been disconnected from the data collectionunit 1205. For example, the fourth lead-wire set contact 1271 d and thefifth lead-wire set contact 1271 e are connected to the first electrodelead 1221 and the second electrode lead 1222. When the fourth lead-wireset contact 1271 d and the fifth lead-wire set contact 1271 e are incontact with the fourth data collection unit contact 1289 d and thefifth data collection unit contact 1289 e, an ECG signal can be obtainedby the data collection unit 1205 from the electrodes 1211 and 1212.

When the lead-wire set 1210 and the data collection unit 1205 areconnected, the second lead-wire set contact 1271 b makes contact withthe second data collection unit contact 1289 b, and the third lead-wireset contact 1271 c makes contact with the third data collection unitcontact 1289 c. The second and third lead-wire set contacts 1271 b and1271 c close an open circuit in the data collection unit 1205 when thelead-wire set connector is connected to the data collection unit 1205,allowing power to be supplied from the power source 1215 in thelead-wire set 1215 so that the subject's ECG data can be obtained. Thisallows the data collection unit 1205 to operate as soon as the lead-wireset 1210 is connected. This also prevents power leakage when thelead-wire set 1210 is disconnected.

When the lead-wire set 1210 and the data collection unit 1205 areconnected, the first lead-wire set contact 1271 a makes contact with thefirst data collection unit contact 1289 a. When the lead-wire set 1210and the data collection unit 1205 are disconnected, contact is brokenbetween the first lead-wire set contact 1271 a and the first datacollection unit contact 1289 a, which in turn sends an interrupt signalto the processor in the data collection unit 1205. The interrupt signalstops the processor from recording data to the non-volatile memorybefore the capacitance in the opened circuit is lost. The interruptsignal helps prevent the non-volatile memory from becoming corrupted.

FIG. 13 shows an example process 1300 for powering a physiological datacollection unit. At 1310, a subject interface is connected to a datacollection unit. When the subject interface is connected to the datacollection unit, the data collection unit is powered on. The subjectinterface can power on the data collection unit by closing an opencircuit between an apparatus load and a power supply. For example, thepower supply can include the power needed to run processing electronicsfor obtaining ECG data from a subject. The power supply can be locatedin the data collection unit. In some examples, the power supply can belocated in the subject interface. At 1320, physiological data isobtained and stored by the data collection unit. The physiological datacan be obtained automatically when the subject interface is connected tothe data collection unit. Accordingly, the subject needs only connectthe subject interface to the data collection unit to power the datacollection unit and to start the data collection unit obtaining andstoring data. At 1330, the subject interface is disconnected. When thesubject interface is disconnected, the data collection unit powers off.Disconnecting the subject interface can power off the data collectionunit by creating an open circuit between the apparatus load and thepower supply. Also, the process 1300 can optionally send an interruptsignal to a processor in the data collection unit when the subjectinterface is disconnected to interrupt storing data to memory in orderto prevent the memory from being corrupted. Also, disconnecting the datacollection unit stops the obtaining and recording of data from thesubject interface.

The disclosed systems, techniques, and all of the functional operationsdescribed and illustrated in this specification can be implemented indigital electronic circuitry, or in computer hardware, firmware,software, or in combinations of the forgoing. For example, one or morecomputers and/or circuitry can be operable to or configured and arrangedto perform the functions and techniques disclosed herein. Apparatusesand/or systems can be implemented using a software product (e.g., acomputer program code) tangibly embodied in a machine-readable storagedevice for execution by a programmable processor, and processingoperations can be performed by a programmable processor executing aprogram of instructions to perform functions by operating on input dataand generating output. Further, the system can be implementedadvantageously in one or more software programs that are executable on aprogrammable system. This programmable system can include thefollowing: 1) at least one programmable processor coupled to receivedata and instructions from, and to transmit data and instructions to, adata storage system; 2) at least one input device; and 3) at least oneoutput device. Moreover, each software program can be implemented in ahigh-level procedural or object-oriented programming language, or inassembly or machine language if desired; and in any case, the languagecan be a compiled or an interpreted language.

Also, suitable processors include, by way of example, both general andspecial purpose microprocessors. Generally, a processor will receiveinstructions and data from a read-only memory, a random access memory,and/or a machine-readable signal (e.g., a digital signal receivedthrough a network connection). The essential elements of a computer area processor for performing instructions and one or more memory devicesfor storing instructions and data. Generally, a computer will includeone or more mass storage devices for storing data files. Such devicescan include magnetic disks, such as internal hard disks and removabledisks, magneto-optical disks, and optical disks. Storage devicessuitable for tangibly embodying software program instructions and datainclude all forms of non-volatile memory, including, by way of example,the following: 1) semiconductor memory devices, such as EPROM(electrically programmable read-only memory); EEPROM (electricallyerasable programmable read-only memory) and flash memory devices; 2)magnetic disks such as internal hard disks and removable disks; 3)magneto-optical disks; and 4) CD-ROM disks. Any of the foregoing can besupplemented by, or incorporated in, ASICs (application-specificintegrated circuits).

The disclosed systems and techniques, described and illustrated in thisspecification can be implemented using a communications network such asa wired or wireless network. Examples of communication networks include,e.g., a local area network (“LAN”), a wide area network (“WAN”), theInternet or any combinations of such.

To provide for interaction with a user (such as the health careprovider), systems can be implemented on a computer system having adisplay device such as a monitor or LCD (liquid crystal display) screenfor displaying information to the user and a keyboard and a pointingdevice such as a mouse or a trackball by which the user can provideinput to the computer system. The computer system can be programmed toprovide a graphical user interface through which computer programsinteract with users.

A number of embodiments have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of the invention. Accordingly, other embodimentsare within the scope of the following claims.

1-22. (canceled)
 23. An ECG kit comprising: a wearable ECG datacollection unit comprising: a non-volatile memory; a processorelectrically connected to the non-volatile memory and configured tostore ECG data in the non-volatile memory and upload ECG data from thenon-volatile memory; and a male data connector electrically connected tothe processor, wherein the male data connector is configured to connect,physically and electrically, to both (i) a wearable ECG subjectinterface and (ii) a computer data port.
 24. The ECG kit of claim 23,wherein the male data connector is a USB connector.
 25. The ECG kit ofclaim 23, wherein the male data connector comprises data collection unitcontacts.
 26. The ECG kit of claim 25, wherein the male data connectoris configured such that the data collection unit contacts electricallyconnect to contacts of the ECG subject interface when the male dataconnector is connected to the ECG subject interface.
 27. The ECG kit ofclaim 26, wherein the wearable ECG data collection unit furthercomprises a power source.
 28. The ECG kit of claim 27, wherein the ECGdata collection unit is configured to stop providing power from thepower source when the ECG subject interface is disconnected from thedata collection unit contacts.
 29. The ECG kit of claim 28, wherein theECG data collection unit is further configured to automatically obtaindata from the ECG subject interface upon the ECG subject interface beingconnected to the ECG data collection unit.
 30. An ECG kit comprising: awearable subject interface; and a wearable ECG data collection unitcomprising: a non-volatile memory; a processor electrically connected tothe non-volatile memory and configured to store ECG data in thenon-volatile memory and upload ECG data from the non-volatile memory;and a male data connector electrically connected to the processor,wherein the data connector is configured to connect, physically andelectrically, to both (1) the wearable subject interface and (2) acomputer data port.
 31. The ECG kit of claim 30, wherein the male dataconnector is a USB connector.
 32. The ECG kit of claim 30, wherein themale data connector comprises data collection unit contacts.
 33. The ECGkit of claim 32, wherein the subject interface includes lead wire setcontacts.
 34. The ECG kit of claim 33, wherein the data connector isconfigured such that the lead wire set contacts on the subject interfaceare electrically connected to the male data connector when the male dataconnector is connected to the subject interface.
 35. The ECG kit ofclaim 34, wherein the ECG data collection unit further comprises a powersource.
 36. The ECG kit of claim 35, wherein the ECG data collectionunit is configured to stop providing power from the power source whenthe subject interface is disconnected from the data collection unitcontacts.
 37. The ECG kit of claim 30, wherein the ECG data collectionunit further comprises a first data collection unit contact and a seconddata collection unit contact, and wherein the subject interfacecomprises a first subject interface contact and a second subjectinterface contact that: when not connected to the first data collectionunit contact and the second data collection unit contact, respectively,are configured to create an open circuit, and when connected to thefirst data collection unit contact and the second data collection unitcontact, respectively, are configured to create a closed circuit. 38.The ECG kit of claim 37, wherein the first data collection unit contactis in series with the second data collection unit contact, and whereinthe subject interface, when connected to the data collection unitcontacts, is configured to bring the first data collection unit contactinto electrical connection with the second data collection unit contact.39. The ECG kit of claim 30, wherein the subject interface comprises apair of electrodes.
 40. The ECG kit of claim 39, wherein the subjectinterface contacts comprise a third subject interface contact and afourth subject interface contact for bringing the pair of electrodesinto electrical communication with the processor.
 41. The ECG kit ofclaim 30, wherein the ECG data collection unit is further configured toautomatically obtain data from the subject interface upon the subjectinterface being connected to the ECG data collection unit.
 42. The ECGkit of claim 30, wherein the ECG data collection unit is configured toautomatically stop obtaining data from the subject interface upon thesubject interface being disconnected from the ECG data collection unit.